Belgium's UCB submits Xyzal NDA to FDA

Belgian pharmaceutical firm UCB says that it has submitted a New Drug Application for Xyzal (levocetirizine dihydrochloride) an antihistamine product for the treatment of allergies, to the US Food and Drug Administration. The drug, which was first launched in Europe in 2001(Marketletters passim), and has since been marketed in 49 countries around the world, is designed to address seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria.

The NDA is based on data from numerous trials, which the firm believes demonstrate the product's safety and efficacy. Roch Doliveux, chief executive of the company, added that "the NDA submission for Xyzal is an alternative for US physicians seeking an effective prescription treatment for patients that do not experience relief from existing medications." The firm added that the product could be of benefit to the estimated 50 million US citizens who suffer from allergies.